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FDA 510(k)

Eviva Stereotactic Guided Breast Biopsy System

K-Number: K180233 · 2018-04-10

ApplicantHologic, Inc.
Decision Date2018-04-10
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Eviva Stereotactic Guided Breast Biopsy System is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2018-04-10 under approval number K180233. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eviva Stereotactic Guided Breast Biopsy System?

Eviva Stereotactic Guided Breast Biopsy System is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Hologic, Inc.. The 510(k) number is K180233.

When was Eviva Stereotactic Guided Breast Biopsy System approved by the FDA?

Eviva Stereotactic Guided Breast Biopsy System received FDA 510(k) clearance on 2018-04-10, under approval number K180233.

What company makes Eviva Stereotactic Guided Breast Biopsy System?

Eviva Stereotactic Guided Breast Biopsy System is manufactured by Hologic, Inc..

What is the FDA product code for Eviva Stereotactic Guided Breast Biopsy System?

The FDA product code for Eviva Stereotactic Guided Breast Biopsy System is KNW.

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Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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